Assessing the Impact of Group Antenatal Care on IPTp Uptake in Tanzania

NCT ID: NCT04148690

Last Updated: 2021-07-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4515 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2021-07-10

Brief Summary

Group antenatal care (GANC) is a service delivery model where women with pregnancies of similar gestational age are brought together for antenatal care (ANC), incorporating information sharing and peer support. This model provides selected aspects of clinical care to women in the group at the same time during group visits, as well as creating a support group of women at a similar stage in pregnancy, to improve the quality of care and engagement of women in the ANC process, ultimately leading to better retention in care. Initial studies have suggested that this improves uptake of intermittent preventive treatment in pregnancy (IPTp) among women who participate, but have not evaluated the effect at community level. The investigators propose to assess whether use of the GANC model in Tanzania can improve the quality of ANC as compared to standard individual ANC, by measuring uptake of recommended interventions, primarily IPTp.

Recent data from Tanzania and Kenya suggest that malaria parasitemia prevalence among pregnant women correlates with the prevalence among children under five, and could be used to track trends over time.3-5 The very high coverage of ANC (>80% attending at least one ANC contact), suggests that pregnant women could be a good sentinel population that could be readily tracked over time. However, pregnant women represent only about 5% of the overall population, thus, it is important to demonstrate that the trends in malaria prevalence and household level coverage of interventions reported by pregnant women attending ANC is representative of coverage among the general population. If validated, these data could be used to augment or even replace the data on coverage of interventions collected through the use of malaria indicator surveys, which are expensive and infrequently conducted, and generally only powered to the regional level.

Detailed Description

Project Background Group antenatal care (GANC) is a service delivery model where women with pregnancies of similar gestational age are brought together for antenatal care (ANC), incorporating information sharing and peer support. This model provides selected aspects of clinical care to women in the group at the same time during group visits, as well as creating a support group of women at a similar stage in pregnancy, to improve the quality of care and engagement of women in the ANC process, ultimately leading to better retention in care. Initial studies have suggested that this improves uptake of intermittent preventive treatment in pregnancy (IPTp) among women who participate, but have not evaluated the effect at community level. The investigators propose to assess whether use of the GANC model in Tanzania can improve the quality of ANC as compared to standard individual ANC, by measuring uptake of recommended interventions, primarily IPTp. Tanzania have been selected as coverage of early ANC is high, with 98% of women receiving ANC from a trained provider in Tanzania and 83% in Benin,1 with a median age of initiation of five and four months, respectively. Coverage of 4 ANC visits, however, is sub-optimal: just 36% in Geita region of Tanzania. Despite the relatively early initiation of ANC, in Tanzania only 56% and 26% of women received two and three doses of IPTp.

Recent data from Tanzania and Kenya suggest that malaria parasitemia prevalence among pregnant women correlates with the prevalence among children under five, and could be used to track trends over time.3-5 The very high coverage of ANC (>80% attending at least one ANC contact), suggests that pregnant women could be a good sentinel population that could be readily tracked over time. However, pregnant women represent only about 5% of the overall population, thus, it is important to demonstrate that the trends in malaria prevalence and household level coverage of interventions reported by pregnant women attending ANC is representative of coverage among the general population. If validated, these data could be used to augment or even replace the data on coverage of interventions collected through the use of malaria indicator surveys, which are expensive and infrequently conducted, and generally only powered to the regional level.

Study Aims

Primary Objectives:

1. GANC: Assess whether GANC is associated with to improved uptake of IPTp; specifically, to assess whether the proportion of pregnant women receiving 3 or more doses of IPTp is higher in the catchment areas of facilities implementing the GANC intervention as compared to the catchment areas of control facilities without GANC.

2. ANC data for surveillance: Pilot data collection from women at 1st ANC and validate whether the results obtained from this population are representative of the population as a whole.

Secondary Objectives:

GANC

1. To assess whether implementation of GANC is associated with to a greater proportion of women completing the recommended number of ANC visits compared to control facilities without GANC.

2. To assess whether the implementation of GANC leads to earlier initiation of ANC compared to control facilities without GANC, as women can only participate in GANC if they present <24 weeks.

3. To assess whether GANC is associated with increased utilization of facility-based delivery

4. To assess whether GANC is associated with improved quality of care (defined as the coverage of key ANC interventions- blood pressure, urine test, blood test, tetanus, iron-folic acid (IFA), albendazole, insecticide treated bednet (ITN), IPTp)

5. To assess the feasibility and acceptability of increasing the coverage of GANC

6. To assess the costs and cost effectiveness of GANC versus individual ANC (standard of care)

ANC data for Surveillance

7. To understand the acceptability to pregnant women and healthcare workers of being asked/asking these additional questions during ANC contacts.

8. To quantify the time per woman required to collect data on coverage of malaria control interventions into ANC

9. To assess the correlation between the prevalence of malaria by rapid diagnostic test (RDT) among pregnant women attending 1st ANC and among children under 5 measured in cross sectional household surveys

10. To explore optimal data collection strategies and determine how best to operationalize them (i.e., should data be collected and recorded by ANC providers or another cadre; e.g., a community health worker stationed at the clinic).

Methodology Study design: This will be a cluster randomized controlled trial conducted over an 18-month period. Facilities will be randomized 1:1 to control and intervention arms. In the control arm, ANC care will be delivered as per standard practice. In the intervention sites, women presenting for first ANC prior to 24 weeks will be offered the opportunity to join group care (as long as there is still space in an appropriate group) starting with the 2nd visit; women presenting after 24 weeks or declining to join a group will receive standard ANC care.

Baseline and end line cross sectional household surveys will be conducted 18 months apart to measure the proportion of women living in the facility catchment areas who have completed a pregnancy (ie. given birth) within the past 12 months in each community who received 1, 2, 3, 4, and 5+ doses of IPTp, the timing of initiation of ANC, number of total ANC visits, facility-based delivery, birth outcomes, as well as validate the representativeness of data on parasite prevalence, insecticide treated net (ITN) ownership and use, and care seeking. The sample size in each country will be sufficient to allow for an estimate of the effect of GANC for each country, as the effectiveness of this model is dependent on the proportion of women who attend ANC early, which is somewhat higher in Benin than in Tanzania.

Implications The results will be used by the Ministries of Health (MOH) in Tanzania to decide: whether to expand the use of GANC as a strategy to improve quality of care and increase utilization of ANC; and whether pregnant women attending first ANC can be used as a sentinel population to improve surveillance of malaria control interventions.

Expected findings and dissemination The investigators will share the results of this study with the MoHs and the partners working in malaria and maternal and child health through: country-based technical working groups in malaria and maternal and newborn health; community leaders; and women's associations-as well as dissemination events and print materials. The findings will contribute to the evidence to determine whether GANC is associated with improved ANC attendance, IPTp uptake, and quality of care (as defined as the delivery of specific interventions), and whether it should be scaled-up in other suitable malaria endemic regions. The findings on ANC surveillance will contribute to the evidence about whether this method of surveillance is effective and should be scaled up. The results will also be presented in both local and international scientific meetings and published in a peer-reviewed journal.

Conditions

Malaria; Malaria in Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Group ANC Intervention

Clinics in the group ANC intervention arm offer group Antenatal Care to women who present for their initial visit prior to 24 weeks provided that they intend to remain in the area for the duration of the pregnancy, and agree to participate in GANC. Women not enrolled in group ANC will receive standard ANC per ministry of health protocols.

Group Type: EXPERIMENTAL

Group antenatal care (GANC)

Intervention Type: OTHER

Group antenatal care (GANC) is a service delivery model where women with pregnancies of similar gestational age are brought together for antenatal care (ANC), incorporating information sharing and peer support.

Routine ANC

Clinics will offer only standard ANC per ministry of health protocols.

Group Type: ACTIVE_COMPARATOR

Standard antenatal care

Intervention Type: OTHER

Routine antenatal care as recommended by th Ministry of Health of Tanzania

Interventions

Group antenatal care (GANC)

Group antenatal care (GANC) is a service delivery model where women with pregnancies of similar gestational age are brought together for antenatal care (ANC), incorporating information sharing and peer support.

Intervention Type: OTHER

Standard antenatal care

Routine antenatal care as recommended by th Ministry of Health of Tanzania

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Pregnant women residing in the facility catchment area, who present for initial ANC visit prior to 24 weeks are eligible to participate in GANC provided that they intend to remain in the area for the duration of the pregnancy, and agree to participate in GANC. All women attending first ANC at participating facilities will be asked to respond to a short list of questions regarding the coverage of malaria control interventions in their household.

• Children between the ages of 6-59 months will be included provided that they are living in households interviewed during the baseline or end line cross sectional survey and a parent or legal guardian provides consent for their participation

• ANC provider who has had at least six months of work experience
• Health facility in-charge
• Health management information system (HMIS) focal person

• In depth interviews may be conducted with program managers (malaria, reproductive health, and statistics/ data collection officers) at the district, regional and national levels

Exclusion Criteria

• Pregnant women: Women will be excluded from participation in GANC if they initiate ANC care >24 weeks gestation, if there are no available groups that they can join, if they do not intend to remain in the facility catchment area for the duration of the study, or if they are not available during the times the group intends to meet. Women will also be excluded if they do not speak Swahili, as group discussions will be conducted in Swahili.

Providers:

• Those who have been working in the health facility for less than six months will not be interviewed due to low levels of relevant experience or exposure to the intervention.

Policy makers:

• None

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jhpiego

OTHER

Sponsor Role: collaborator

Ministry of Health, Tanzania

OTHER_GOV

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Responsible Party

Julie Gutman

Medical Officer, Strategic and Applied Science Unit, Malaria Branch

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruth Lemwayi, MD

Role: PRINCIPAL_INVESTIGATOR

Jhpiego

Julie R Gutman, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Mary Drake

Role: PRINCIPAL_INVESTIGATOR

Jhpiego

Locations

Chato District Hospital

Chato, , Tanzania

Countries

Tanzania

Other Identifiers

7226 GANC-TZ

Identifier Type: -

Identifier Source: org_study_id